Now-recalled Biocell textured breast implants are at the center of another proposed class action lawsuit, this time filed by 14 pseudonymous plaintiffs who claim they never received adequate warning that the products increased their risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. The recall notwithstanding, the lawsuit alleges defendants Allergan, Inc. (formerly Inamed Corporation), Allergan USA, Inc., and Allergan plc have failed to cover the full cost of removing and replacing the implants, as well as medical monitoring.
According to the case, of the reports of 573 cases of BIA-ALCL received by the FDA, 481 (or 84 percent) were attributed to Allergan products. The agency noted that the risk of developing BIA-ALCL is six times higher with Allergan’s textured breast implants than alternative products from other manufacturers, the suit states.
For its part, Allergan, the lawsuit alleges, attempted to hide from patients and doctors the risks associated with its Biocell saline- and silicone-filled textured breast implants by refusing to file adverse event reports with the FDA. The case claims Allergan, instead of accurately reporting individual ruptures and injuries as required by law, chose to “bury evidence” by classifying such incidents as “routine events” that did not require public disclosure. The lawsuit points out that when the FDA implemented more rigorous reporting requirements in 2017, the number of adverse events related to breast implant injuries rose dramatically.
“It went from 200 a year, to 4,567 in 2017 and 8,242 in the first half of 2018,” the complaint reads.
The case goes on to explain that although the FDA issued several warnings concerning a potential link between textured breast implants and BIA-ALCL between March 2017 and February 2019, Allergan continued to manufacture and sell the products without alerting patients to the associated health risks. Allergan, the suit claims, was aware of the “well-documented” risks associated with its products since at least 2011 yet refused to issue a recall until it was pressured to do so by the FDA in July 2019, the suit says. From the complaint:
“It was not until July 24, 2019 that Allergan announced a worldwide recall of all BIOCELL textured breast implants and tissue expanders. It waited this long despite knowing for years about the growing data that these devices were unsafe and could cause cancer. And it did not properly disclose this information to patients.”
The plaintiffs claim the recall is insufficient in that Allergan has refused to pay for the removal of the recalled products and any medical consequences associated with the surgeries required to do so. Further, the case alleges proposed class members have been unfairly forced to shoulder the cost of medical monitoring associated with mitigating the “substantially increased risk” of developing BIA-ALCL. The plaintiffs say they would never have chosen Allergan’s Biocell implants had they known of the risks and costs associated with the allegedly defective products. The lawsuit seeks to require that Allergan cover such costs and any other damages arising from its allegedly defective products:
Plaintiffs bring this Action to make Allergan take responsibility for exposing women to a higher risk of BIA-ALCL and to make all women implanted with these defective devices whole by covering all costs associated with the removal, replacement, and recovery, medical monitoring, and all damages arising out of the sale and implanting of these defective devices.
The full list of recalled products can be read in the complaint below.